Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Subjects With Systemic Sclerosis With Interstitial Lung Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01559129
First received: March 19, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

The purpose of this first study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of pomalidomide (CC-4047) in the treatment of subjects with systemic sclerosis with interstitial lung disease.


Condition Intervention Phase
Scleroderma, Systemic
Sclerosis, Systemic
Systemic Scleroderma
Systemic Sclerosis
Drug: Pomalidomide (CC-4047)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Type, frequency, severity and relationship of Adverse Events (AE) and Serious Adverse Events to pomalidomide [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE

  • Change from Baseline (Week 0) of the forced vital capacity (FVC) at Week 52 in Systemic Sclerosis subjects [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) is a pulmonary function test. Pulmonary function tests will be assessed at multiple time points by a central vendor throughout the study. Spirometry assessments will include the following parameters: - FVC: Volume of air that can forcibly be blown out after full inspiration - Forced expiratory volume (FEV)1: Maximum volume of air that can forcibly be blown out in the first second during the FVC maneuver, measured in liters (will only be assessed at Screening)

  • Change from Baseline (Week 0) of the modified Rodnan Skin Score (mRSS) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Improvement in skin thickening is associated with improved survival and may be useful as a surrogate measurement in clinical studies. The mRSS is an assessment tool which is used to evaluate the extent and severity of the skin thickening associated with Systemic Sclerosis (SSc). Seventeen body areas are evaluated on a 4-point scale (0 [normal], 1 [mild], 2 [moderate], or 3 [severe]). The total score, which is the sum of the 17 individual body assessments, can range from 0 to 51.

  • Change from Baseline of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) total score in Systemic Sclerosis subjects [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT


Secondary Outcome Measures:
  • Area Under the Time Curve (AUCt) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from 0 to 6 hours

  • Pharmacokinetic Parameter -Cmax [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    The maximum observed plasma concentration of CC-220 after multiple doses of CC-220

  • Pharmacokinetic Parameter - Tmax [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    The time to first maximum observed plasma concentration of CC-220 after multiple doses.

  • Change from Baseline (Week 0) of the FVC at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    Forced vital capacity (FVC) is a pulmonary function test. Pulmonary function tests will be assessed at multiple time points by a central vendor throughout the study.

    Spirometry assessments will include the following parameters:

    • FVC: Volume of air that can forcibly be blown out after full inspiration
    • Forced expiratory volume (FEV)1: Maximum volume of air that can forcibly be blown out in the first second during the FVC maneuver, measured in liters (will only be assessed at Screening)

  • Change from Baseline (Week 0) of the Modified Rodnan Skin Score at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Improvement in skin thickening is associated with improved survival and may be useful as a surrogate measurement in clinical studies. The mRSS is an assessment tool which is used to evaluate the extent and severity of the skin thickening associated with SSc. Seventeen body areas are evaluated on a 4-point scale (0 [normal], 1 [mild], 2 [moderate], or 3 [severe]). The total score, which is the sum of the 17 individual body assessments, can range from 0 to 51.

  • Change from Baseline (Week 0) of the UCLA SCTC GIT 2.0 total score at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT.

  • Change from Baseline (Week 0) UCLA SCTC GIT 2.0 subscale scores (Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional Well-being and Constipation) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT.

  • Change from Baseline (Week 0) of the oxygen saturation (as measured by pulse oximetry) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The collection of pulse oximetry data is necessary whenever a patient's oxygenation may be unstable, as in the case of subjects with pulmonary-related conditions. The assessment is a non-invasive method which allows for the monitoring of the oxygenation of a subject's hemoglobin. Sites may select the type of pulse oximeter they wish to use. Each subject's assessments must be completed using the same type of oximeter.

  • Change from Baseline (Week 0) dyspnea (as measured by the Transition Dyspnea Index) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The BDI and TDI Indexes provide interview-based measurements of breathlessness related to activities of daily living. The BDI is a discriminative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) at a single point in time. The TDI is an evaluative instrument that includes specific criteria for each of three components to measure changes from a baseline state. At baseline, dyspnea is rated using five grades from 0 (severe) to 4 (unimpaired) for each category to form a baseline score (0 - 12). During the transition period, the TDI assesses changes in dyspnea using seven grades ranging from -3 (major deterioration) to +3 (major improvement). The ratings for each of the three categories are then added to form a total transition focal score (range, -9 to +9).

  • Change from Baseline (Week 0) of the forced vital capacity (FVC) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) is a pulmonary function test. Pulmonary function tests will be assessed at multiple time points by a central vendor throughout the study. Spirometry assessments will include the following parameters: - FVC: Volume of air that can forcibly be blown out after full inspiration - Forced expiratory volume (FEV)1: Maximum volume of air that can forcibly be blown out in the first second during the FVC maneuver, measured in liters (will only be assessed at Screening).

  • Change from Baseline (Week 0) and Week 24 of the modified Rodnan Skin Score (mRSS) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Improvement in skin thickening is associated with improved survival and may be useful as a surrogate measurement in clinical studies. The mRSS is an assessment tool which is used to evaluate the extent and severity of the skin thickening associated with SSc. Seventeen body areas are evaluated on a 4-point scale (0 [normal], 1 [mild], 2 [moderate], or 3 [severe]). The total score, which is the sum of the 17 individual body assessments, can range from 0 to 51.

  • Change from Baseline in the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) total score at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT.

  • Change from Baseline in the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) subscore (Reflux, Distention, Bloating, Fecal Silage, Social functioning, Emotional Well-being and Constipation s at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT.

  • Change from Baseline in the oxygen saturation (as measured by pulse oximetry) in Systemic Sclerosis subjects at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    The collection of pulse oximetry data is necessary whenever a patient's oxygenation may be unstable, as in the case of subjects with pulmonary-related conditions. The assessment is a non-invasive method which allows for the monitoring of the oxygenation of a subject's hemoglobin. Sites may select the type of pulse oximeter they wish to use. Each subject's assessments must be completed using the same type of oximeter.

  • Change from Baseline (Week 0) in dyspnea (as measured by the Transition Dyspnea Index (TDI) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    The BDI and TDI Indexes provide interview-based measurements of breathlessness related to activities of daily living. The BDI is a discriminative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) at a single point in time. The TDI is an evaluative instrument that includes specific criteria for each of three components to measure changes from a baseline state. At baseline, dyspnea is rated using five grades from 0 (severe) to 4 (unimpaired) for each category to form a baseline score (0 - 12). During the transition period, the TDI assesses changes in dyspnea using seven grades ranging from -3 (major deterioration) to +3 (major improvement). The ratings for each of the three categories are then added to form a total transition focal score (range, -9 to +9).

  • Change from Baseline (Week 0) of the forced vital capacity (FVC) at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) is a pulmonary function test. Pulmonary function tests will be assessed at multiple time points by a central vendor throughout the study. Spirometry assessments will include the following parameters: - FVC: Volume of air that can forcibly be blown out after full inspiration - Forced expiratory volume (FEV)1: Maximum volume of air that can forcibly be blown out in the first second during the FVC maneuver, measured in liters (will only be assessed at Screening).

  • Change from Baseline (Week 0) of the forced vital capacity (FVC) at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) is a pulmonary function test. Pulmonary function tests will be assessed at multiple time points by a central vendor throughout the study. Spirometry assessments will include the following parameters: - FVC: Volume of air that can forcibly be blown out after full inspiration - Forced expiratory volume (FEV)1: Maximum volume of air that can forcibly be blown out in the first second during the FVC maneuver, measured in liters (will only be assessed at Screening).

  • Change from Baseline in the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) subscore (Reflux, Distention, Bloating, Fecal Silage, Social functioning, Emotional Well-being and Constipation s at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT.

  • Change from Baseline in the oxygen saturation (as measured by pulse oximetry) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The collection of pulse oximetry data is necessary whenever a patient's oxygenation may be unstable, as in the case of subjects with pulmonary-related conditions. The assessment is a non-invasive method which allows for the monitoring of the oxygenation of a subject's hemoglobin. Sites may select the type of pulse oximeter they wish to use. Each subject's assessments must be completed using the same type of oximeter.

  • Change from Baseline (Week 0) in dyspnea (as measured by the Transition Dyspnea Index (TDI) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The BDI and TDI Indexes provide interview-based measurements of breathlessness related to activities of daily living. The BDI is a discriminative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) at a single point in time. The TDI is an evaluative instrument that includes specific criteria for each of three components to measure changes from a baseline state. At baseline, dyspnea is rated using five grades from 0 (severe) to 4 (unimpaired) for each category to form a baseline score (0 - 12). During the transition period, the TDI assesses changes in dyspnea using seven grades ranging from -3 (major deterioration) to +3 (major improvement). The ratings for each of the three categories are then added to form a total transition focal score (range, -9 to +9).

  • Change from Baseline (Week 0) and Week 52 of the forced vital capacity (FVC) at Weeks 64, 76, 88, 100, 104, 128, 156 [ Time Frame: Baseline to week s 64, 76, 88, 100, 104, 128 and 156 ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) is a pulmonary function test. Pulmonary function tests will be assessed at multiple time points by a central vendor throughout the study. Spirometry assessments will include the following parameters: - FVC: Volume of air that can forcibly be blown out after full inspiration - Forced expiratory volume (FEV)1: Maximum volume of air that can forcibly be blown out in the first second during the FVC maneuver, measured in liters (will only be assessed at Screening).

  • Change from Baseline (Week 0) and Week 52 of the modified Rodnan Skin Score (mRSS) at Weeks 64, 76, 104, 128, 156 [ Time Frame: Baseline to Weeks 64, 76, 104, 128 and 156 ] [ Designated as safety issue: No ]
    Improvement in skin thickening is associated with improved survival and may be useful as a surrogate measurement in clinical studies. The mRSS is an assessment tool which is used to evaluate the extent and severity of the skin thickening associated with SSc. Seventeen body areas are evaluated on a 4-point scale (0 [normal], 1 [mild], 2 [moderate], or 3 [severe]). The total score, which is the sum of the 17 individual body assessments, can range from 0 to 51.

  • Change from Baseline and Week 52 in the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) total score at Weeks 64, 76, 104, 128 and 156 [ Time Frame: Baseline to Weeks 64, 76, 104, 128 and 156 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT.

  • Change from Baseline and Week 52 in the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) subscore (Reflux, Distention, Bloating, Fecal Silage, Social functioning, Emotional Well-being and Constipation) [ Time Frame: Baseline to Weeks 64, 76, 104, 128 and 156 ] [ Designated as safety issue: No ]
    The UCLA SCTC GIT 2.0, which has been shown to correlate with other quality-of-life assessments, such as the SF-36, is a 34-item, health-related quality of life self-administered, evaluation tool, which targets GI activity and severity in subjects with SSc. Individual scales include, Reflux, Distention/Bloating, Fecal Soilage, Diarrhea, Social functioning, Emotional well-being and Constipation. The items are scored on a 0 to 3 range, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). In addition to the 7 scale scores, scores from 6 of the 7 scales (excluding constipation) can be combined to form a total GIT score. The total score captures overall burden (severity) of SSc-associated GIT.

  • Change from Baseline and Week 52 in the oxygen saturation (as measured by pulse oximetry) at Weeks 64, 76, 104, 128 and 156 [ Time Frame: Baseline to weeks 64, 76, 88, 100, 104, 128 and 156 ] [ Designated as safety issue: No ]
    The collection of pulse oximetry data is necessary whenever a patient's oxygenation may be unstable, as in the case of subjects with pulmonary-related conditions. The assessment is a non-invasive method which allows for the monitoring of the oxygenation of a subject's hemoglobin. Sites may select the type of pulse oximeter they wish to use. Each subject's assessments must be completed using the same type of oximeter.

  • Change from Baseline (Week 0 and Week 52) in dyspnea (as measured by the Transition Dyspnea Index (TDI) at Weeks 64, 76, 104, 128 and 156 [ Time Frame: Baseline to weeks 64, 76, 88, 100, 104, 128 and 156 ] [ Designated as safety issue: No ]
    The BDI and TDI Indexes provide interview-based measurements of breathlessness related to activities of daily living. The BDI is a discriminative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) at a single point in time. The TDI is an evaluative instrument that includes specific criteria for each of three components to measure changes from a baseline state. At baseline, dyspnea is rated using five grades from 0 (severe) to 4 (unimpaired) for each category to form a baseline score (0 - 12). During the transition period, the TDI assesses changes in dyspnea using seven grades ranging from -3 (major deterioration) to +3 (major improvement). The ratings for each of the three categories are then added to form a total transition focal score (range, -9 to +9).


Enrollment: 23
Study Start Date: July 2012
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pomalidomide (1 mg once daily) Drug: Pomalidomide (CC-4047)
1 mg orally every day for 52 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or females between 18 and 80 years of age (inclusive) at the time of consent
  • Diagnosis of SSC as defined by ACR criteria
  • Onset of the first non-Raynaud's manifestation of SSC within 7 years of Screening
  • Subjects are required to meet at least one of the following 2 pulmonary-related criteria to be eligible for the study:
  • Repeat FVC at Baseline (Visit 2) within 5% of the FVC measured at Screening
  • Carbon monoxide diffusing capacity (DLco) ≥ 35% and ≤ 80% of predicted value at Screening
  • Abnormalities on high resolution computed tomography consistent with sclerodermatous involvement of the lung (eg, ground glass, honeycombing)

FVC ≥ 45% and <70% at Screening and Baseline (Visit 2) [with or without a documented pre-specified FVC decline or fibrosis score]

OR

FVC readings ≥ 70% and ≤ 80% at Screening and Baseline (Visit 2) with a documented history of either or both of:

  1. A ≥ 5% decrease (expressed as percent predicted or in liters) in FVC in the 24-month period prior to Baseline (Visit 2) based on 3 or more assessments. Two assessments may be done during the Screening phase provided the assessments are completed at least 2 weeks apart.
  2. An HRCT fibrosis score > 20%

Exclusion Criteria:

  • Oxygen saturation (SpO2) < 92% (room air [sea level] at rest) at Screening or Baseline
  • Known diagnosis of obstructive lung disease as defined by forced expiratory volume (FEV1)/FVC ratio < 0.7
  • Diagnosis of pulmonary arterial hypertension (PAH) requiring treatment
  • Known diagnosis of other significant respiratory disorders (e.g., asthma, tuberculosis, sarcoidosis, aspergillosis, chronic bronchitis, neoplastic disease, cystic fibrosis, etc.)
  • Current clinical diagnosis of another inflammatory connective tissue disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, etc.)
  • Use of melphalan within 52 weeks of Screening
  • Additional concomitant medications which prolong the QT/QTc interval (measure of heart's electrical cycle) during the course of the study
  • Use of any anti-coagulant or anti-thrombotic medications (other than low dose-aspirin [(≤ 100 mg/day)
  • Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 10 mg/day [mean dose] or equivalent), including but not limited to azathioprine, cyclophosphamide, methotrexate, mycophenolate and cyclosporine within 28 days (4 weeks) of Screening
  • Use of any biologic agent within 84 days (12 weeks) or 5 half-lives of Screening. In the case of rituximab, use within 168 days (24 weeks) of Screening or no recovery of CD20-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to Screening
  • Use of bosentan, ambrisentan, sildenafil, tadalafil and macitentan for PAH within 28 days (4 weeks) of Screening
  • Use of medications (e.g., D-penicillamine, Potaba) with putative scleroderma disease-modifying properties within 4 weeks of Screening
  • Use of any investigational drug within 4 weeks of Screening or 5 pharmacodynamic/pharmacokinetic half-lives if known (whichever is longer)
  • Smoking of cigars, pipes or cigarettes within 24 weeks of Screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559129

  Show 49 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: William Smith, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01559129     History of Changes
Other Study ID Numbers: CC-4047-SSC-001, 2010-023047-15
Study First Received: March 19, 2012
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Switzerland: Ethikkommission
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
United States: Institutional Review Board
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Pomalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014